The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Alkaline Phosphatase In Serum.
| Device ID | K781609 |
| 510k Number | K781609 |
| Device Name: | ALKALINE PHOSPHATASE IN SERUM |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-19 |
| Decision Date | 1978-10-24 |